510(k) K090625

WIRELESS PORTABLE DETECTOR FD-W17 by Philips Medical Systems North America Co. — Product Code MQB

K090625 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "WIRELESS PORTABLE DETECTOR FD-W17". The FDA issued a decision of Substantially Equivalent on March 24, 2009. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems North America Co. has at least 10 other 510(k) clearances on record.